NIH Public Access Policy Mandating Zero Embargo Now in Effect

Effective today, the NIH Public Access Policy is in effect and manuscripts accepted for publication in a journal on or after July 1, 2025, must be submitted to PubMed Central for public availability without embargo upon the official date of publication.

To assist with compliance, NIH has developed a new website dedicated to the Public Access Policy which includes an overview of the policy, supplemental guidance, tips for submitting to PubMed Central, contact information, and FAQs.  The site can be found at: https://grants.nih.gov/policy-and-compliance/policy-topics/public-access.

Questions can be sent to [email protected].

NIH and FDA Publish Glossary of Clinical Research Terms Related to Innovative Clinical Trial Design

The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have published a new glossary of clinical research terms related to innovative clinical trial design, including studies using real-world data to generate real-world evidence. This glossary is intended to facilitate communication within the clinical research community by establishing a common vocabulary.

The glossary can be viewed here. In addition, leaders from both NIH and FDA have authored an article published in JAMA Network Open that describes the joint agency effort.

Questions can be sent to [email protected]

NIH Implementation of Executive Order on Improving the Safety and Security of Biological Research

Pursuant to the May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research, NIH is requiring all NIH awardees to review their research portfolios to identify NIH funding and other support for projects meeting the definition of dangerous gain-of-function research. Review must be complete by June 30, 2025. NIH will also be suspending or terminating awards as directed by Executive Order. For more information please see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-127.html

Questions may be sent to [email protected]. If you are not yet a subscriber to this listserv, please sign up here.   

Thoughts on the Recent NIH DURC Stakeholder Engagement Meeting

On Thursday, NIH held its second stakeholder engagement meeting on components of the U.S. government biosecurity oversight framework. As I prepared for this meeting and collected my thoughts around the meetings that ultimately shaped the current USG DURC policies, it struck me that it has been almost 17 years to the day since the inaugural (June 30, 2005) meeting of the National Science Advisory Board for Biosecurity (NSABB).  I couldn’t help but start to think about the technological differences between now and 2005.  For example, on the day of that first NSABB meeting, the list of things that did not exist include: smartphones, free Wi-Fi, widespread use of electronic health records, and, of course, ubiquitous use of social media.

The remarkable pace of technological development, when applied to biomedical research, is equally, if not more, staggering. As a scientist, I’ll admit I’m thrilled to see how science is being used to make our lives better. However, as a policymaker, I’m extremely cognizant of the importance of ensuring the science we support maximizes the benefits while minimizing risks. After a decade since the NSABB helped shape the first USG DURC policy, we thought it imperative to take a fresh look at our DURC policies to ensure they’ve kept pace.

As part of its series of public sessions related to biosecurity, this week NIH heard from a variety of stakeholders including institutional officials, researchers, policy experts, and other members of the public on the USG’s DURC oversight framework.  The meeting featured three sessions focused on the DURC policy scope and definition, policy implementation and effects, and potential future considerations for oversight.

For those of you who were unable to attend (and even those who were), I wanted to share a few of the major highlights of the meeting. 

  • Multiple speakers emphasized that the DURC policies provide a good overarching framework in which the degree of oversight is justifiable. There was good discussion on whether the classification of agents and experimental types was the most effective strategy moving forward.
  • Some speakers thought that the scope should be expanded to encompass non-federally funded research, and there was much discussion of how the democratization of biology necessitates consideration of bottom-up approaches to risk mitigation.
  • Communication.  Communication.  Communication.  It was very clear from the discussions and public comment portion that effective communication is critical to ensuring robust oversight of DURC and the success of these policies. Just a few ideas included sharing best practices beyond the academic institution and dedicated efforts to promote understanding and transparency in policy development.

These are just a few of the key takeaways I heard from the meeting. Importantly, this meeting is only one step in the NIH approach to engaging the stakeholder community on this issue. There will be another stakeholder engagement meeting later in 2022. All of the information we are collecting will also help inform the deliberations of the NSABB as they work on their current charge.

In case you were unable to join us earlier this week, I hope you have found this recap helpful.  If you were in attendance, please let me know if I left anything out!  Finally, a recording of the full meeting will soon be available on the NIH Videocast if you are interested in seeing the action for yourself.

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric